RUGBY ARTIFICIAL TEARS- mineral oil and white petrolatum ointment 
Rugby Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients                                        Purpose

Mineral oil 15%............................................Lubricant

White petrolatum 83%..................................Lubricant

Uses

  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
  • may be used as a protectant against further irritation

Warnings

For external use only

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • the condition worsens or persists more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • pull down the lower lid of the affected eye and apply a small amount (1/4") of ointment to the inside of eyelid

Other information

  • store away from heat
  • protect from freezing
  • use before expiration date marked on container
  • store at 59°-86°F (15°-30°C)

Inactive ingredient

lanolin alcohol

Distributed by:

Rugby Laboratories

17177 N Laurel Park Dr.

Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Made in Korea

image description

RUGBY ARTIFICIAL TEARS 
mineral oil and white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1086
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM830 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1086-911 in 1 CARTON11/08/2016
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/10/201510/17/2019
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 10/2021
 
Rugby Laboratories, Inc.